The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).

. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

. Hip: Capsular repair, acetabular labral repair.

Device Description

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

AI/ML Overview

The provided text is a 510(k) Summary for the Arthrex SwiveLock Suture Anchor, a medical device for orthopedic fixation. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory submission to the FDA, not a study report on the performance of an AI/ML powered device, therefore, it does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The sections you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in documents related to the validation and performance evaluation of AI/ML software as a medical device (SaMD). This 510(k) is for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence through mechanical testing and biocompatibility.

Therefore, I cannot extract the requested information from the provided text.

Summary

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January 15, 2020

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Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K193503

Trade/Device Name: Arthrex SwiveLock Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: December 12, 2019 Received: December 18, 2019

Dear Ms. Singelais:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Laura Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K193503

Device Name Arthrex SwiveLock Suture Anchor

Indications for Use (Describe)

The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

. Hip: Capsular repair, acetabular labral repair.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared	January 15, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Jessica L. SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@arthrex.com
Name of Device	Arthrex SwiveLock Suture Anchor
Common Name	Smooth or threaded metallic bone fixation fastener
Product Code	MAI, MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener21 CFR888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K191226: Arthrex SwiveLock Suture Anchor
Reference Device	K173240: Arthrex PushLock Suture Anchor
Purpose of Submission	This Special 510(k) premarket notification is submitted to add a line extension to theArthrex SwiveLock Suture Anchors cleared under predicate K191226.
Device Description	The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised ofan eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mountedon a driver with the anchor body and eyelet physically separated on the driver shaft.Arthrex 510(k) cleared suture may also be provided with the device.
Indications for Use	The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue)to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the followingprocedures:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, CapsularShift or Capsulolabral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, MetatarsalLigament Repair/Tendon Repair and Bunionectomy.Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), MedialCollateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique Ligament Repair and Illiotibial BandTenodesis and Quadriceps Tendon Repair, Secondary fixation for ACL/PCLreconstruction or repair (4.75-5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or RadialCollateral Ligament Reconstruction.Hip: Capsular repair, acetabular labral repair.
ComparisonSummary ofTechnologicalCharacteristics andModificationsProposed	The proposed device is a line extension to the predicate device. The proposed andpredicate devices (K191226) have the same basic design, intended use, indications foruse, packaging and sterilization method. In comparison to the predicate device, theproposed device has an extended shelf life. Proposed modifications consist of amodified eyelet, knotless suture construct and suture manufacturing processchanges. Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.

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Performance Data	Cyclic pull-out, biocompatibility testing per ISO 10993-1:2018 and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate.
Conclusion	The proposed Arthrex SwiveLock Suture Anchors are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex SwiveLock is substantially equivalent to the currently marketed predicate device.

Performance Data

Cyclic pull-out, biocompatibility testing per ISO 10993-1:2018 and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate.

Conclusion

The proposed Arthrex SwiveLock Suture Anchors are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex SwiveLock is substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.